PRINCETON, N.J. - Bristol Myers Squibb (NYSE:BMY) has reported positive outcomes from the Phase 3b/4 PSORIATYK SCALP trial of Sotyktu (deucravacitinib) for patients with moderate-to-severe scalp psoriasis. The trial achieved its primary endpoint, with a significant improvement in the scalp-specific Physician's Global Assessment (ss-PGA) response at week 16. Results indicated that 48.5% of patients treated with Sotyktu achieved clear or almost clear skin compared to 13.7% of those on placebo.
The trial also met key secondary endpoints, including a greater percentage of patients achieving a 90% improvement in Psoriasis Scalp Severity Index (PSSI) response and a change from baseline in scalp-specific itch. These findings were presented at the European Academy of Dermatology and Venereology (EADV) Congress in Amsterdam.
Additionally, the safety profile of Sotyktu in the trial was consistent with previous studies, with common adverse events being nasopharyngitis, upper respiratory tract infection, acne, headache, COVID-19, and pustular acne.
Parallel to the clinical trial data, an interim analysis of the real-world RePhlect registry confirmed the consistent effectiveness of Sotyktu in treating moderate-to-severe plaque psoriasis. The registry data showed significant decreases in disease severity measures after six months of treatment.
Dr. Mark Lebwohl, an investigator and paid consultant for Bristol Myers Squibb, emphasized the impact of scalp psoriasis on quality of life and the effectiveness of Sotyktu as a once-daily oral treatment. Daniel Quirk, senior vice president, highlighted the potential of Sotyktu to become a systemic therapy of choice for healthcare providers treating adult patients with moderate-to-severe psoriasis.
Sotyktu is the first selective TYK2 inhibitor in clinical studies across multiple immune-mediated diseases. The PSORIATYK SCALP trial and RePhlect study involved patients with moderate-to-severe scalp psoriasis and moderate-to-severe plaque psoriasis, respectively.
The information is based on a press release statement from Bristol Myers Squibb.
In other recent news, Bristol-Myers Squibb (NYSE:BMY) has received FDA approval for its schizophrenia treatment, COBENFY™. This is a significant development, given the absence of the typical black box warning. The drug is expected to be marketed at a list price of $1,850 for a 30-day supply. Analysts from firms such as Morgan Stanley, JPMorgan, BMO Capital, and Goldman Sachs have responded positively to this development. The FDA approval confirms the value of Bristol-Myers Squibb's $12.7 billion acquisition of Karuna, the original developer of the drug.
Furthermore, the company reported sustained reductions in brain volume loss in patients with relapsing forms of multiple sclerosis treated with Zeposia, according to the Phase 3 DAYBREAK trial. Bristol-Myers Squibb's blood thinner Eliquis has also been selected by the Biden administration for price negotiations with the Medicare health program.
The approval of COBENFY™ is anticipated to positively impact Zai Lab (NASDAQ:ZLAB)'s financial performance and share value in the coming years, as the company had previously secured the Greater China rights to COBENFY™. Morgan Stanley's projections for COBENFY™'s risk-adjusted revenue by 2030 estimate $600 million. These are the latest developments in both Bristol-Myers Squibb's and Zai Lab's ongoing activities in the pharmaceutical industry.
InvestingPro Insights
Bristol Myers Squibb's positive clinical trial results for Sotyktu align with the company's strong position in the pharmaceutical industry. According to InvestingPro data, BMY boasts a substantial market capitalization of $104.88 billion, reflecting its significant presence in the market.
The company's revenue growth of 2.93% over the last twelve months and a more impressive 8.69% growth in the most recent quarter suggest that new treatments like Sotyktu could contribute to future financial performance. This growth potential is particularly noteworthy given BMY's already robust revenue of $46.51 billion in the last twelve months.
InvestingPro Tips highlight that Bristol Myers Squibb is a "prominent player in the Pharmaceuticals industry," which is evident from its continued innovation in treatments like Sotyktu. Additionally, the company "has maintained dividend payments for 54 consecutive years," demonstrating a long-term commitment to shareholder returns. This is further supported by a current dividend yield of 4.79%, which may be attractive to income-focused investors.
While the company faces some challenges, such as the expectation that "net income is expected to drop this year," the strong clinical trial results and real-world data for Sotyktu could potentially offset some of these concerns. The stock's recent performance is also noteworthy, with a "strong return over the last three months" of 22.58%, possibly reflecting market optimism about BMY's pipeline and current product portfolio.
For investors seeking more comprehensive analysis, InvestingPro offers 10 additional tips for Bristol Myers Squibb, providing a deeper understanding of the company's financial health and market position.
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